Feasibility and acceptability of NIDUS-professional, a training and support intervention for homecare workers caring for clients living with dementia: a cluster-randomised feasibility trial.

INTRODUCTION: In the first randomised controlled trial of a dementia training and support intervention in UK homecare agencies, we aimed to assess: acceptability of our co-designed, manualised training, delivered by non-clinical facilitators; outcome completion feasibility; and costs for a future trial. METHODS: This cluster-randomised (2:1) single-blind, feasibility trial involved English homecare agencies. Intervention arm agency staff were offered group videocall sessions: 6 over 3 months, then monthly for 3 months (NIDUS-professional). Family carers (henceforth carers) and clients with dementia (dyads) were offered six to eight complementary, individual intervention sessions (NIDUS-Family). We collected potential trial measures as secondary outcomes remotely at baseline and 6 months: HCW (homecare worker) Work-related Strain Inventory (WRSI), Sense of Competence (SoC); proxy-rated Quality of Life (QOL), Disability Assessment for Dementia scale (DAD), Neuropsychiatric Inventory (NPI) and Homecare Satisfaction (HCS). RESULTS: From December 2021 to September 2022, we met agency (4 intervention, 2 control) and HCWs (n = 62) recruitment targets and recruited 16 carers and 16/60 planned clients. We met a priori progression criteria for adherence (≥4/6 sessions: 29/44 [65.9%,95% confidence interval (CI): 50.1,79.5]), HCW or carer proxy-outcome completion (15/16 (93.8% [69.8,99.8]) and proceeding with adaptation for HCWs outcome completion (46/63 (73.0% [CI: 60.3,83.4]). Delivery of NIDUS-Professional costs was £6,423 (£137 per eligible client). WRSI scores decreased and SoC increased at follow-up, with no significant between-group differences. For intervention arm proxy-rated outcomes, carer-rated QOL increased, HCW-rated was unchanged; carer and HCW-rated NPI decreased; DAD decreased (greater disability) and HCS was unchanged. CONCLUSION: A pragmatic trial is warranted; we will consider using aggregated, agency-level client outcomes, including neuropsychiatric symptoms.

A process evaluation of the NIDUS-Professional dementia training intervention for UK homecare workers.

INTRODUCTION: This process evaluation was conducted in parallel to the randomised controlled feasibility trial of NIDUS-Professional, a manualised remote dementia training intervention for homecare workers (HCWs), delivered alongside an individualised intervention for clients living with dementia and their family carers (NIDUS-Family). The process evaluation reports on: (i) intervention reach, dose and fidelity; (ii) contexts influencing agency engagement and (iii) alignment of findings with theoretical assumptions about how the intervention might produce change. METHODS: We report proportions of eligible HCWs receiving any intervention (reach), number of sessions attended (dose; attending ≥4/6 main sessions was predefined as adhering), intervention fidelity and adherence of clients and carers to NIDUS-Family (attending all 6-8 planned sessions). We interviewed HCWs, managers, family carers and facilitators. We integrated and thematically analysed, at the homecare agency level, qualitative interview and intervention recording data. RESULTS: 32/141 (23%) of eligible HCWs and 7/42 (17%) of family carers received any intervention; most who did adhered to the intervention (89% and 71%). Intervention fidelity was high. We analysed interviews with 20/44 HCWs, 3/4 managers and 3/7 family carers, as well as intervention recordings involving 32/44 HCWs. All agencies reported structural challenges in supporting intervention delivery. Agencies with greater management buy-in had higher dose and reach. HCWs valued NIDUS-Professional for enabling group reflection and peer support, providing practical, actionable care strategies and increasing their confidence as practitioners. CONCLUSION: NIDUS-Professional was valued by HCWs. Agency management, culture and priorities were key barriers to implementation; we discuss how to address these in a future trial.

Setting individualised goals for people living with dementia and their family carers: A systematic review of goal-setting outcome measures and their psychometric properties.

BACKGROUND: Individualised goal-setting outcome measures can be a useful way of reflecting people living with dementia and family carers' differing priorities regarding quality-of-life domains in the highly heterogeneous symptomatology of the disease. Evaluating goal-setting measures is challenging, and there is limited evidence for their psychometric properties. AIM: (1) To describe what goal-setting outcomes have been used in this population; (2) To evaluate their validity, reliability, and feasibility in RCTs. METHOD: We systematically reviewed studies that utilised goal-setting outcome measures for people living dementia or their family carers. We adapted a risk of bias and quality rating system based on the COSMIN guidelines to evaluate the measurement properties of outcomes when used within RCTs. RESULTS: Thirty studies meeting inclusion criteria used four different goal-setting outcome measures: Goal Attainment Scaling (GAS), Bangor Goal Setting Interview (BGSI), Canadian Occupational Performance Measure (COPM) and Individually Prioritized Problems Assessment (IPPA); other papers have reported study-specific goal-setting attainment systems. Only GAS has been used as an outcome over periods greater than 9 months (up to a year). Within RCTs there was moderate quality evidence for sufficient content validity and construct validity for GAS, COPM and the BGSI. Reliability was only assessed in one RCT (using BGSI); in which two raters reviewed interview transcripts to rate goals with excellent inter-rater reliability. Feasibility was reported as good across the measures with a low level of missing data. CONCLUSION: We found moderate quality evidence for good content and construct validity and feasibility of GAS, BGSI and COPM. While more evidence of reliability of these measures is needed, we recommend that future trials consider using individualised goal setting measures, to report the effect of interventions on outcomes that are most meaningful to people living with dementia and their families.

Association between anxiety symptoms and Alzheimer's disease biomarkers in cognitively healthy adults: A systematic review and meta-analysis.

OBJECTIVE: Anxiety has been identified as both a risk factor and prodromal symptom for Alzheimer's disease (AD) and related dementias, however, the underlying neurobiological correlates remain unknown. The aim of this systematic review and meta-analysis was to examine the association between anxiety symptoms and two defining markers of AD neuropathology: amyloid-beta (Aß) and tau. METHODS: Systematic literature searches were conducted across 5 databases. Studies investigating the relationship between anxiety and AD neuropathology (i.e., Aß and/or tau) in cognitively healthy adults were eligible. Where possible, effect sizes were combined across studies, for Aß and tau separately, using random-effects meta-analyses. Sensitivity analyses were performed to assess whether results differed according to anxiety type (i.e., state and trait) and biomarker assessment modality (i.e., positron emission tomography and cerebrospinal fluid). RESULTS: Twenty-seven studies reporting data from 14 unique cohorts met eligibility criteria. Random-effects meta-analyses revealed no associations between self-reported anxiety symptoms and either Aß (13 studies, Fisher's z = 0.02, 95% confidence interval [CI] -0.01-0.05, p = 0.194) or tau (4 studies, Fisher's z = 0.04, 95% CI -0.02-0.09, p = 0.235). Results remained unchanged across sensitivity analyses. CONCLUSIONS: In cognitively healthy adults, meta-analytic syntheses revealed no associations between anxiety symptoms and either Aß or tau. There is a critical need, however, for larger studies with follow-up periods to examine the effect of anxiety symptom onset, severity, and chronicity on AD neuropathology. Additionally, further research investigating other potential neurobiological correlates is crucial to advance scientific understanding of the relationship between anxiety and dementia.

Feasibility and acceptability of NIDUS-Professional, a training and support intervention for homecare workers caring for clients living with dementia: a cluster-randomised feasibility trial protocol.

INTRODUCTION: Most people living with dementia want to remain living in their own homes, and are supported to do so by family carers and homecare workers. There are concerns that homecare is often unable to meet the needs of this client group, with limited evidence regarding effective interventions to improve it for people living with dementia. We have developed a training and support programme for homecare workers (NIDUS-Professional) to be delivered alongside support sessions for people living with dementia and their family carers (NIDUS-Family). We aim to assess (1) its acceptability among homecare workers and employing agencies, and (2) the feasibility of homecare workers, people living with dementia and their family carers completing the outcomes of intervention in a future randomised controlled trial. METHODS AND ANALYSIS: This is a cluster-randomised (2:1) single-blind, multisite feasibility trial. We aim to recruit 60-90 homecare workers, 30-60 clients living with dementia and their family carers through 6-9 English homecare agencies. In the intervention arm, homecare staff will be offered six group sessions on video call over three months, followed by monthly group sessions over the subsequent three-month period. Outcome measures will be collected at baseline and at six months. ETHICS AND DISSEMINATION: The study received ethical approval on 7 January 2020 from the Camden & King's Cross Research Ethics Committee. Study reference: 19/LO/1667. Findings will be disseminated through a peer-reviewed journal, conference presentation and blog to research and clinical audiences; we will attend forums to present findings to participating homecare agencies and their clients. TRIAL REGISTRATION NUMBER: ISRCTN15757555.

The Association Between Personality Disorder Traits and Suicidality Following Sudden Bereavement: A National Cross-Sectional Survey.

Personality disorder is associated with increased risk of suicidal behavior. The authors aimed to investigate the association between number of personality disorder traits and suicidality risk following sudden bereavement. A secondary analysis of cross-sectional data on 3,167 young adults in the United Kingdom who had experienced sudden bereavement investigated the association between number of traits (measured using a standardized screening instrument) and postbereavement suicide attempt and suicidal ideation. Using multivariable logistic regression, the authors found a linear relationship between number of traits and suicide attempt (adjusted odds ratio [AOR] = 1.36, 95% CI [1.23, 1.49]) and suicidal ideation (AOR = 1.31, 95% CI [1.25, 1.38]) following bereavement. This represented an increase in odds by 36% and 31%, respectively, for each additional personality trait. The authors suggest that individuals with a greater number of traits suggestive of a personality disorder diagnosis are at increased risk of suicidality after a negative life event.

The effect of remotely delivered lifestyle interventions on cognition in older adults without dementia: A systematic review and meta-analysis.

Up to 40% of dementias may be preventable via risk factor modification. This inference has motivated the development of lifestyle interventions for reducing cognitive decline. Typically delivered to older adults face-to-face, the COVID-19 pandemic has necessitated their adaptation for remote delivery. We systematically reviewed randomized controlled trials of remotely delivered lifestyle interventions (≥4 weeks duration and delivered >50% remotely), for adults aged ≥ 60 without dementia, examining effects on objective cognitive measures. Comparators were active (face-to-face or remote) or passive. Ten studies (n = 2967) comprising multidomain (k = 4), physical activity (k = 3) or psychosocial (k = 3) remote interventions were included. Data were synthesized using robust variance estimation meta-analysis. The pooled estimate comparing the effect of remote interventions versus comparators on cognition was not significant (g=-0.02; 95%CI [-0.14, 0.09]; p = .66); subgroup analyses by type of intervention or comparator also yielded non-significant effects. Most studies had low risk of bias. Current evidence to support remote lifestyle interventions is limited. Included studies were conducted pre-pandemic, and evaluated individual, rather than group interventions. Future studies may exploit the greater digital connectivity of older people since the pandemic. Group formats, more frequently efficacious than individual interventions in face-to-face dementia prevention trials, may be a rational approach for future remote trials.

Behavioural Activation for Depression in Informal Caregivers: A Systematic Review and Meta-Analysis of Randomised Controlled Clinical Trials.

BACKGROUND: Carers experience significant physical and psychological burden and are at increased risk of experiencing clinical depression. Although several psychological treatments have been shown to be effective for preventing and treating depression in carers, most are complex, costly, and not easily accessible to family carers. In this paper, we review evidence of effectiveness of Behavioural Activation (BA) for depressive symptoms in informal caregivers and report on its quality. METHODS: We searched MEDLINE, EMBASE, PsycINFO, CINAHL, CENTRAL and Online trial registers for randomised controlled clinical trials of BA for carers. RESULTS: Twelve trials met inclusion criteria and eleven were included in the meta-analyses. BA reduced depressive symptoms for carers (standardised mean difference (SMD) -0.68; confidence interval (CI) -1.14 to -0.22) at post intervention (4-14 weeks) and in the long term (l year; SMD -0.99; CI -1.26 to -0.71). BA decreased risk of a diagnosis of major depression (Odds Ratio 0.35; CI 0.19 to 0.67), and reduced negative affect (SMD -0.53; 95% CI -0.83 to -0.23), and caregiver burden (SMD -0.32; CI -0.55 to -0.09) at post-treatment. Quality of evidence was moderate and there was no evidence of publication bias. LIMITATIONS: There was high heterogeneity in the studies included. CONCLUSION: BA is effective in reducing depressive symptoms post-treatment and long-term (1 year) and decreases odds of a diagnosis of major depression in informal caregivers. Our review provides further evidence that BA is an effective psychological intervention, which is potentially highly scalable across many settings, populations and cultures (Registration: PROSPERO-CRD42019138860).